MAUDE Adverse Event Report: ARTHREX, INC. BONE REDUCTION FORCEPS, CURVED, POINTED; MANUAL INSTR, GENERAL SURGICAL

Model Number	BONE REDUCTION FORCEPS, CURVED, POINTED
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 07/22/2024, it was reported by a sales representative via sems(b)(6) that (2) ar-8943-07 bone reduction forceps were bent.This occurred during a case where another set that had forceps that connected was used to proceed.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-8943-07 bone reduction forceps lot number: 6671827 was received for evaluation.Visual evaluation noted that one of the instrument's curved pointed tip was bent.No functional testing was performed because of the damage to the instrument.The most likely cause for the reported failure can be attributed to wear and tear incurred from repeated use.Manufactured date: 27-nov-2018.

• Brand Name: BONE REDUCTION FORCEPS, CURVED, POINTED
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 20016651
• Report Number: 1220246-2024-07191
• Device Sequence Number: 7448814
• Product Code: MDM
• UDI-Device Identifier: 00888867052178
• UDI-Public: 00888867052178
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BONE REDUCTION FORCEPS, CURVED, POINTED
• Device Catalogue Number: AR-8943-07
• Device Lot Number: 6671827
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown